Abstract
BackgroundFear of cancer recurrence (FCR) is common in people affected by breast cancer. FCR is associated with increased health service and medication use, anxiety, depression and reduced quality of life. Existing interventions for FCR are time and resource intensive, making implementation in a National Health Service (NHS) setting challenging. To effectively manage FCR in current clinical practice, less intensive FCR interventions are required. Mini-AFTERc is a structured 30-min counselling intervention delivered over the telephone and is designed to normalise moderate FCR levels by targeting unhelpful behaviours and misconceptions about cancer recurrence.This multi-centre non-randomised controlled pilot trial will investigate the feasibility of delivering the Mini-AFTERc intervention, its acceptability and usefulness, in relation to specialist breast cancer nurses (SBCNs) and patients. This protocol describes the rationale, methods and analysis plan for this pilot trial of the Mini-AFTERc intervention in everyday practice.MethodsThis study will run in four breast cancer centres in NHS Scotland, two intervention and two control centres. SBCNs at intervention centres will be trained to deliver the Mini-AFTERc intervention. Female patients who have completed primary breast cancer treatment in the previous 6 months will be screened for moderate FCR (FCR4 score: 10‑14). Participants at intervention centres will receive the Mini-AFTERc intervention within 2 weeks of recruitment. SBCNs will audio record the intervention telephone discussions with participants. Fidelity of intervention implementation will be assessed from audio recordings. All participants will complete three separate follow-up questionnaires assessing changes in FCR, anxiety, depression and quality of life over 3 months. Normalisation process theory (NPT) will form the framework for semi-structured interviews with 20% of patients and all SBCNs. Interviews will explore participants’ experience of the study, acceptability and usefulness of the intervention and factors influencing implementation within clinical practice. The ADePT process will be adopted to systematically problem solve and refine the trial design.DiscussionFindings will provide evidence for the potential effectiveness, fidelity, acceptability and practicality of the Mini-AFTERc intervention, and will inform the design and development of a large randomised controlled trial (RCT).Trial registrationClinicalTrials.gov: NCT0376382. Registered 4th December 2018, https://clinicaltrials.gov/ct2/show/NCT03763825
Highlights
Fear of cancer recurrence (FCR) is common in people affected by breast cancer
Mini-AFTERc is the first brief FCR intervention, designed to assist individuals to manage moderate levels of FCR before they progress to more severe level and require a more intensive face-to-face psychological intervention
Preliminary feasibility work is promising, suggesting that Mini-AFTERc can feasibly be integrated into existing end-of-treatment cancer care practice, is acceptable to current cancer care staff and can effectively reduce FCR in patients affected by breast cancer [17, 18]
Summary
Aim and objectives The aim of this pilot trial is to investigate the acceptability and feasibility of delivering the Mini-AFTERc intervention in every day clinical practice. An effect size of 0.5 at 0.85 power would require a sample of 130 patients to robustly demonstrate any effect of the intervention on patients’ fear of cancer recurrence, assuming a standard deviation of 7 between pre and post FCR measures, derived from a previous feasibility study [17], and an attrition rate of 30%. Follow-up assessment Participants in the intervention group will complete the consultation and relational empathy (CARE) [30] and the medical interview satisfaction scale (MISS) [31] within 1 or 2 weeks following their telephone discussion to measure acceptability. A sampling matrix (see supplementary file 2) will ensure a representative sample of patients is recruited based on age, research site, trial group (control/intervention), and retention post-screening (attended/ dropped-out). Findings from the quantitative data and analysis of interview data, from the perspective of patients and SBCNs, will support the decision-making process
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